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CGMP Audits

PharmaSys has extensive experience auditing cGMP quality systems and organizations. Our auditors have experience with the following operations:

  • Finished Pharmaceutical Manufacturing

  • Finished Pharmaceutical Packaging

  • Biotech Manufacturing

  • Blood Fractionization

  • Aceptic Fill/Finish

  • Oinments, Creams/Liquids

  • Medical Device Manufacturing Manufacturing/Packaging

  • Supplier Audits

Types of Audits

Clinical Site Audits

Clinical Data & Study Audits

GLP Audits

Mock FDA Inspections

Compliance Audits

PAI Inspection Readiness

Computer Validation

21CFR Part 11 Audits

IV&V Audits

Our professional auditors have extensive experience in their respective fields and are available to fly anywhere in the world at a moment's notice.

"PharmaSys had an audit team onsite within days of our request. They were instrumental in the timely review of our clinical data allowing us to complete our NDA in record time."

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